BD and its subsidiary C.R. Bard has issued a Class I recall, the most serious type, for several esophagogastric balloon tamponade tubes because of difficulties in removing plastic plugs from the device’s rubber lumens.
The tubes are used in emergency situations to control bleeding in the esophagus and stomach, according to a May 23 FDA news release. The recall affects all lots of five devices, including the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube and multiple models of the Bard Blakemore Esophageal Nasogastric Tube.
The recall does not remove the products from the shelves but provides updated instructions for safely preparing them for use. Healthcare providers are advised to follow new instructions using a specific type of hemostat to remove the plugs and have backup devices ready.
BD has reported two serious injuries and one death related to the issue.
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